Astellas has withdrawn its application to market Vibative (telavancin) for adult complicated skin and soft tissue infections in Europe, but plans to submit a new application in 2009 that includes an indication for hospital-acquired pneumonia.
Whether the new marketing authorization application will include the indication for cSSTI has not yet been decided.
Withdrawal of the MAA followed an opinion from EMEA's Committee for Medicinal Products for Human Use that data provided to the agency were insufficient to conclude there is a positive benefit-risk balance for Vibativ in the cSSTI indication.
The new application will contain data from Phase III studies of HAP treatment with telavancin not available at the time the initial marketing authorization application was sent to the European Medicines Agency in May 2007, reports Theravance, the drug's developer.
Theravance is leading development and regulatory activities for telavancin in the U.S. for cSSTI and HAP; Astellas is responsible for obtaining approval of the drug elsewhere.
The regulatory delay in Europe does not necessarily bode ill for FDA review of telavancin for cSSTI. Theravance was able to add safety data from the HAP studies as a supplement to its original NDA, the firm says. The company expects to submit an application for HAP by the end of 2008 or early in 2009.
If approved, telavancin would be Theravance's first commercial product. Telavancin is a novel, once-daily injectable antibiotic designed to treat infections caused by gram-positive bacteria, including resistant pathogens, such as methicillin-resistant staphylococcus aureus.
Telavancin is one of two drugs on the schedule for a Nov. 19 FDA Anti-Infective Drugs Advisory Committee meeting (1"The Pink Sheet" DAILY, Oct. 16, 2008).
The agency has not set an agenda for that discussion. But Theravance notes that the meeting originally was scheduled for February and at that time the agency said it wanted to discuss telavancin's renal affects, QTc, non-inferiority margins, use in pregnancy and overall risk/benefit. General issues related to non-inferiority margins for complicated skin infections will be discussed by the anti-infectives panel on Nov. 18.
Results of telavancin's clinical trials for HAP were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy and Infectious Diseases Society of America conference in Washington, D.C., Oct. 25-28. Telavancin "achieved numerically higher cure rates than conventional therapy for treatment of HAP in severely ill and older patients with comparable treatment-emergent adverse events," according to E. Rubinstein, University of Manitoba, et. al.
The February meeting was postponed by an FDA investigation of clinical trial sites for the drug. FDA findings caused the removal of efficacy data for 73 of 1,867 patients but did not impact the study results, Theravance said during its third quarter earnings call on Oct. 23.
-Cathy Dombrowski (c.dombrowski@elsevier.com)
This article is reprinted from "The Pink Sheet" DAILY – Oct. 28, 2008
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